Clinical trial · Interventional
Natural Killer (NK) Cell Therapy for B-Cell Malignancies
QN-019a as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies in Subjects With B-Cell Malignancies
NCT05379647CI-TRIAL-00058573unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, Phase I study of QN-019a (allogeneic CAR-NK cells targeting CD19) as monotherapy in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and in combination with Rituximab in relapsed/refractory B-cell Lymphoma. This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL. Up to 22-36 patients will be enrolled.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamid | Drug | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
| QN-019a | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| VP-16 | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- QN-019a in Combination with Monoclonal Antibodies
- description
- QN-019a in Combination with Rituximab in adult subjects with r/r B-cell lymphoma.
- interventionNames
- Drug: QN-019a
- Drug: Rituximab
- Drug: Cyclophosphamid
- Drug: Fludarabine
- Drug: VP-16
- type
- EXPERIMENTAL
- label
- QN-019a Monotherapy
- description
- QN-019a Monotherapy in adult subjects with r/r B-ALL
- interventionNames
- Drug: QN-019a
- Drug: Cyclophosphamid
- Drug: Fludarabine
- Drug: VP-16
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Diagnosis of B-cell lymphoma or B-ALL as described below: B-cell Lymphoma: * Histologically documented lymphomas expected to express CD19 and CD20 * Relapsed/refractory disease following at least two prior systemic treatment regimens, or relapsed after the autologous hematopoietic stem cell transplantation (HSCT) B-ALL: * Diagnosis of B-ALL that expected to express CD19 * Relapsed/refractory disease following prior systemic treatment regimens ALL SUBJECTS: * Provision of signed and dated informed consent form (ICF) * Age ≥ 18 years old * Stated willingness to comply with study procedures and duration * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 * Adequate organ function as defined in the protocol * Donor specific antibody (DSA) to QN-019a: MFI \<= 2000 * At least 3 weeks after the last systemic immunochemotherapy treatment * The estimated survival days are expected to be over 3 months Key Exclusion Criteria: ALL SUBJECTS: * Females who are pregnant or lactating * Evidence of insufficient organ function as defined in the protocol * ECOG Performance Status ≥2 * Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T/CAR-NK within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy * Currently receiving or likely to require systemic immunosuppressive therapy * Known active central nervous system (CNS) involvement by malignancy. Non-malignant CNS disease such as stroke, epilepsy, or neurodegenerative disease * Clinically significant cardiovascular disease as defined in the protocol * Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection * Donor specific antibody (DSA) to QN-019a: MFI \> 2000 * Other comorbid conditions and concomitant medications prohibited as per study protocol * Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
References
Publications (0)
Data not yet available
No reference posted for this study.